Table 4.
Patient characteristics for the JULIET ITT and CORAL follow-up ITT populations, unadjusted analyses
| Characteristic | JULIET (N = 166) | CORAL follow-up (N = 205) | P |
|---|---|---|---|
| Confounders | |||
| Age at initial diagnosis | .001* | ||
| ≤60 y | 107 (64.5%) | 166 (81.0%) | |
| >60 y | 59 (35.5%) | 39 (19.0%) | |
| Mean ± SD, y | 53.3 ± 12.7 | 49.9 ± 11.4 | .007* |
| Ann Arbor disease stage | .028* | ||
| I or II | 35 (21.1%) | 49 (32.7%) | |
| III or IV | 131 (78.9%) | 101 (67.3%) | |
| Extranodal site involvement | <.001* | ||
| 0-1 | 94 (56.6%) | 116 (76.3%) | |
| ≥2 extranodal organs | 72 (43.4%) | 36 (23.7%) | |
| Status of disease | .318 | ||
| Relapsed after last line | 68 (41.0%) | 100 (48.8%) | |
| Refractory to all lines | 30 (18.1%) | 31 (15.1%) | |
| Refractory to last line but not to all lines | 68 (41.0%) | 74 (36.1%) | |
| Time to 2L start after diagnosis | .112 | ||
| <12 mo | 94 (57.7%) | 99 (48.3%) | |
| ≥12 and ≤24 mo | 41 (25.2%) | 54 (26.3%) | |
| >24 mo | 28 (17.2%) | 52 (25.4%) | |
| Serum LDH level | 1.000 | ||
| Normal (LDH ≤ ULN) | 59 (35.5%) | 50 (35.2%) | |
| Elevated (LDH > ULN) | 107 (64.5%) | 92 (64.8%) | |
| ECOG performance status | — | ||
| 0-1 | 166 (100.0%) | 31 (100.0%) | |
| Prior HCT† | .554 | ||
| Yes | 74 (44.6%) | 84 (41.0%) | |
| No | 92 (55.4%) | 121 (59.0%) | |
| No. of relapses excluding refractory‡ | |||
| Mean ± SD | 1.4 ± 0.9 | 1.4 ± 0.9 | .636 |
| Median (minimum, maximum) | 1.0 (0.0, 4.0) | 2.0 (0.0, 5.0) | .528 |
| Other baseline variables | |||
| Age, y | |||
| Mean ± SD, y | 55.8 ± 12.9 | 52.7 ± 11.5 | .016* |
| Sex | .965 | ||
| Female | 62 (37.3%) | 75 (36.6%) | |
| Male | 104 (62.7%) | 130 (63.4%) | |
| Ann Arbor disease stage at diagnosis | .033* | ||
| I or II | 42 (26.4%) | 77 (37.6%) | |
| III or IV | 117 (73.6%) | 128 (62.4%) | |
| IPI§ | .172 | ||
| <2 risk factors | 33 (19.9%) | 15 (12.9%) | |
| ≥2 risk factors | 133 (80.1%) | 101 (87.1%) | |
| No. of prior lines of therapies | |||
| Mean ± SD | 2.9 ± 1.2 | 2.3 ± 0.7 | <.001* |
| Median (minimum, maximum) | 3.0 (1.0, 8.0) | 2.0 (2.0, 6.0) | <.001* |
Unless otherwise indicated, numbers and percentages were only summarized among non-missing observations. –, p not calculated; ECOG, Eastern Cooperative Oncology Group; IPI, International Prognostic Index; LDH, lactate dehydrogenase; SD, standard deviation; ULN, upper limit of normal.
P < .05.
Prior HCT only included prior autoHCT because records with prior alloHCT were excluded.
The number of relapses was defined as the total number of lines before the index treatment in which the patient had a CR or partial response and relapsed later.
The IPI includes the following risk factors: age >60 years, elevated LDH, stage III or IV disease, ECOG performance status ≥2, and ≥2 extranodal sites.